JPH0775672A - Injection cylinder body for injector in common use as chemical container - Google Patents

Abstract

PURPOSE:To enable encapsulating of dry chemicals into an injection cylinder body at a low cost by forming and providing the cylindrical wall of a cylindrical part upper than an intermediate plug part with a vent bypass formed by expanding the diameter of a part of the cylindrical mold in such a manner that both top and bottom ends thereof exist on the inside surface of the cylindrical mold and that the vertical length thereof is set longer than the vertical thickness of the outer peripheral surface of the intermediate plug. CONSTITUTION:The cylindrical part 1a is formed and provided with the vent bypass 8 formed by expanding the diameter of a part of the cylindrical wall on the cylindrical wall between the intermediate plug part and the opening at the top end. The vertical length L2 of the vent bypass 8 is set longer than the vertical thickness D1 of the intermediate plug 50 consisting of a rubber material inserted into the intermediate plug part. The injection cylinder 1 injects the liquid chemicals into a dry chemical chamber 13 in the state of fitting a hole plug 52 into the cavity in the nozzle part 10 in the bottom at the bottom end and mounting a protective cover 53 at its bottom end. The liquid chemicals are freeze-dried by operation of a freeze-drying machine. The dry chemical chamber 13 and the opening are communicated with each other via the vent bypass 8 and the steam removed from the chemicals in the process of freeze drying is expelled outside through the vent bypass 8.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a drug container / syringe in which an injectable drug is pre-encapsulated in a syringe barrel body of an injector, and an injectable drug to be enclosed in the syringe barrel body is A syringe that also serves as a drug container in the form of a lyophilized drug and a solution that dissolves the drug, and the drug is dissolved by the solution inside the barrel of the syringe during the injection procedure. Regarding the improvement of the main body of the syringe.

[0002] Injectables are filled and sealed in small drug containers (ampoules or vials) at the time of manufacture, shipped and distributed, and at the time of use, after the drug solution is sucked from the drug container into the injection cylinder, it is then transferred from the injection cylinder to a patient or the like. The traditional method of injecting into the body is common today. However, in recent years, a drug container / injector, in which an injectable drug is preliminarily loaded inside a syringe barrel body, has begun to be used under a name such as a pre-filled syringe. Prevents misuse, erroneous operation, contamination by foreign substances and damage to the needle tip of the injection needle due to the transfer of the drug solution from the drug container to the syringe barrel of the syringe, and the highly viscous or thixotropic drug solution is transferred to the syringe barrel in case of an urgent illness that is in hurry. This is to save labor and time for suction.

The liquid is unstable and freeze-dried in a chemical container at the time of manufacture, and the in-use dissolution freeze-dried injection, which is distributed as a solution attached to a container separate from the dry chemical container, is a rapid biotechnology product. However, the procedure at the time of use is more complicated than that of liquid injection. That is, after the dissolution liquid is sucked from the dissolution liquid container into the syringe barrel body of the syringe, it is injected into the dry medicine container from the syringe barrel body to dissolve the dry medicine, and the dissolved drug solution is stored in the syringe barrel body. Must be re-aspirated and injected into the body. In the case of such in-use injectable drug, widespread use of the drug container / syringe is expected. The present invention improves and spreads a drug container / syringe for a lyophilized injection.

[0004]

2. Description of the Related Art A conventional drug container / syringe A for a lyophilized injection has an injection cylinder body 1 having a nipple-like nozzle portion 10 for mounting an injection needle on the bottom bottom of a cylindrical portion 1a, and its nozzle. A double-headed injection needle 2 attached to the portion 10, and a plunger 3 to be inserted from an opening 11 at an upper end of the injection barrel body 1.
And a dry chemical 4 which can be loaded into the cylindrical portion 1a of the syringe barrel body 1.
The intermediate portion 50 to be inserted into the cylindrical portion 1a so as to seal it, and the cylindrical portion 1 so as to seal the solution 6 to be injected into the cylindrical portion 1a.
It is composed of a liquid chamber stopper 51 which is fitted and inserted into the upper end side in a, and a hole stopper 52 which is fitted and inserted into the nozzle portion 10 (Fig. 6).

As shown in FIG. 1, an injection cylinder main body 1 used for this medicine container / syringe A has an opening 11 at the upper end and a nipple-like nozzle portion 10 for mounting an injection needle 2 at the bottom bottom part. A glass cylindrical body having a diameter of about 12 mm (inner diameter 10 mm), a hole plug 52 made of a rubber material such as synthetic rubber is fitted inside the nozzle portion 10, and a rubber is attached to the tip of the nozzle portion 10. A protective cover 21 made of material is attached. The syringe barrel body 1 includes a cylindrical portion 1a above the nozzle portion 10 which is sealed by the hole stopper 52, in the order from the lower end to the upper portion, a dry chemical chamber 13, a liquid bypass (a liquid flow passage). ) 14, intermediate plug portion 15, dissolution liquid chamber 16, liquid chamber plug portion 17
Etc. are formed. FIG. 2 is a transverse cross-sectional view of the syringe barrel body 1 of FIG. 3 is a front view of an intermediate plug 50 fitted into the intermediate plug portion 15 inside the syringe barrel body 1, and FIG. 4 is a liquid chamber plug 51 fitted into the liquid chamber plug portion 17 of the syringe barrel body 1. In the front view, both the intermediate plug 50 and the liquid chamber plug 51 shown in the drawings are formed of a rubber material such as synthetic rubber into a disk shape or a cylindrical shape. The liquid chamber stopper 51 has a female screw 510 formed on the upper surface side. Further, the intermediate stopper 50 and the liquid chamber stopper 51 are respectively manufactured in the process of manufacturing the syringe barrel body 1 of the drug container / syringe A with the dry drug 4 and the solution 6 enclosed therein. It is attached to the intermediate plug part 15 and the liquid chamber plug part 17 in 1 and airtightly shuts off the inside of the syringe barrel body 1 separated by them. Further, when the medicine container / syringe A is used as a syringe, it is airtightly slid in the syringe barrel body 1 by the operation of the operator. Further, the plunger 3 is attached so as to be connected to the liquid chamber stopper 51 during this use.
Further, the double-headed injection needle 2 having blade edges at both ends is also attached to the nozzle portion 10 at the bottom bottom of the injection barrel main body 1 during use. The hole plug 52 fitted in the inner cavity of the nozzle portion 10
In this example, when the nipple-shaped cap body 10a formed separately from the cylindrical portion 1a is fitted onto the outer periphery of the base end portion 10b of the nozzle portion 10, the lower end surface of the base end portion 10b is And the inner end surface of the cap body 10a, the inner cavity of the nozzle portion 10 is sealed.

The steps of loading the freeze-dried dry chemical 4 and the solution 6 into the interior of the injection barrel body 1 of the chemical container / syringe A are performed in the following order.

The syringe barrel body 1 is fitted with a hole plug 52 in the inner cavity of the nipple-shaped nozzle portion 10 at the bottom thereof to seal it, and a protective cover 53 is attached to the outer periphery of the tip of the nozzle portion 10. To the state shown in FIG.

Next, a prescribed amount of the drug solution is injected into the dry chemical chamber 13 at the bottom of the syringe barrel body 1, and a predetermined number of the syringe barrel bodies 1 in this state are erected upright on a test tube vertical metal holder. The drug 4 in the syringe barrel body 1 is freeze-dried and dried by operating the freeze-dryer by placing it on the shelf surface of the shelf in the freeze-drying chamber of the freeze-dryer. To do.

Next, the air pressure inside the syringe barrel body 1 is adjusted to a pressure inside the freeze-drying chamber of the freeze-drying machine or inside the air-tight chamber separately provided outside the machine, the intermediate plug 50 is inserted into the syringe barrel body 1. The intermediate stopper which is formed into a cylindrical shape from the opening 11 on the upper end side of the syringe barrel body 1 in such a state that the pressure in the dry chemical chamber 13 is adjusted to the atmospheric pressure when pushed to the position of the portion 15. 50 is pushed to the position of the intermediate plug portion 15 to seal the dry chemical chamber 13.

Next, a predetermined amount of the solution 6 is injected into the solution chamber 16 whose upper surface is the bottom surface of the intermediate stopper 50, and the solution chamber stopper 51 is provided and the solution chamber 16 is sealed. To do.

As a result, as shown in FIG. 5, the dried medicine 4 is enclosed in the dry medicine chamber 13 and the solution 6 thereof is enclosed in the solution chamber 16. The manufacturing process of is completed.

The operation of the thus-manufactured syringe barrel body 1 during use is carried out according to the following procedure.

First, the plunger 3 is placed on the upper surface of the liquid chamber stopper 51.
Connect the lower end side of. A female screw is usually machined on the head of the liquid chamber stopper 51, and the tip of the plunger 3 having a male screw at the tip is connected to this female screw as shown in FIG. 6, and the plunger 3 is pushed down.

As a result, the liquid chamber stopper 51 and the dissolving liquid 6 are pushed down, and the intermediate stopper 50 is also lowered together. And
When the descending intermediate plug 50 reaches the position of the liquid passage bypass 14, the vertical length L1 of the liquid passage bypass 14 is longer than the upper and lower thickness D1 of the intermediate plug 50, so that the intermediate plug 50 of FIG. As described above, the solution 6 stopped in the upper and lower intermediate positions of the solution bypass 14 leaks into the dry chemical chamber 13 through the solution bypass 14 circumscribing the cylindrical surface of the intermediate plug 50. , The dry chemical 4 in the dry chemical chamber 13 is dissolved.

Next, when the solution 3 is completely sent to the dry chemical chamber 13 by further pushing down the plunger 3, the upper surface of the intermediate stopper 50 is brought into close contact with the lower surface of the liquid chamber stopper 51, so that the intermediate The stopper 50 begins to descend again together with the descending liquid chamber stopper 51, the lower surface of the intermediate stopper 50 passes the lower end of the liquid passage bypass 14, and the dry chemical 4 is dissolved by the dissolving liquid 6 as shown in FIG. The chemical solution M is contained in the dry chemical chamber 13. These operations are performed with the injection cylinder body 1 in an upright position with the nozzle portion 10 located at the lower end, so that only a part of the gas in the dry chemical chamber 13 is contained in the liquid bypass 14 and dissolved. The entire amount of the chemical liquid M is sealed between the lower surface of the intermediate plug 50 and the hole plug 52.

Next, after the liquid bypass 14 is blocked from the dry chemical chamber 13 by the intermediate plug 50, the protective cover 53 attached to the nozzle portion 10 is removed, and the injection needle 2 is attached to the nozzle portion 10. . When the injection needle 2 is attached, the disk-shaped rubber hole plug 52 is broken by the blade end on the proximal end side of the injection needle 2, and the dry chemical chamber 13 communicates with the outside through the inner cavity of the injection needle 2. When the plunger 3 is pushed in, the drug solution M is discharged from the tip of the injection needle 2 into a state of the drug container / syringe A.

Next, the medicine container / syringe A is changed, and the gas in the dry medicine chamber 13 is removed from the needle tip of the injection needle 2 (FIG. 9). After the gas is completely removed, the injection needle 2 is pierced into a predetermined portion of the patient, and the plunger 3 is pushed in to push down the liquid chamber stopper 51 and the intermediate stopper 50, thereby functioning as a piston head surface. The medicinal solution M is injected into the body until the front surface of the intermediate stopper 50 is pressed against the lower end surface of the syringe barrel body 1.

In the manufacturing process in which the dry medicine 4 and the solution 6 are enclosed in the syringe barrel body 1 of this prior art, after the drug solution is freeze-dried, the intermediate plug 50 is inserted from the opening 11 at the upper end of the syringe barrel body 1 into the middle. The step of pushing the stopper 15 to the position to seal the dry chemical chamber 13 is a step of isolating and sealing the freeze-dried chemical 4 from the outside, that is, contamination, moisture absorption, oxidation, etc. This is one of the most important steps of freeze-dried injections in which final sterilization after sealing is not possible because it is disliked. However, in the prior art, any one of the following methods has been adopted.

(No. 1) As shown in FIG. 10, a predetermined number of the injection cylinder main bodies 1 into which the chemicals have been injected are supported upright on a test tube stand-shaped metal holder 70, and a shelf in the freeze-drying chamber of the freeze-drying machine. When arranging on the shelf surface of the step, it is upward from the opening 11 on the upper end side of each injection barrel main body 1 to an accurate position just above the arrangement position of each injection barrel main body 1 determined by the structure of the holder 70. And the intermediate plugs 5 ...
The push rod 71 into which 0 is pushed is supported by the holder 70, and freeze-drying is performed by operating the freeze-dryer (the small arrow in the figure indicates the steam flow path). After the freeze-drying is completed, aseptic dry nitrogen gas is introduced up to a predetermined pressure into the freeze-drying chamber of the freeze-drying machine, and the shelf vertical drive device equipped in the freeze-drying machine is used to move the racks of each shelf. A push rod 71 that can be supported by the holder 70 on the back surface (bottom surface) of each shelf by reducing the interval.
The intermediate plug 50 through the opening 1 at the upper end of the syringe barrel body 1.
Insert into 1 and seal. After that, the shelf intervals of the freeze dryer are opened, and the syringe barrel bodies 1 ... Having the sealed dry chemicals 4 are carried out from the freeze dryer chamber together with the holder 70. Intermediate stopper 5
The step of pushing 0 to the position of the intermediate plug part 15 in the syringe barrel body 1 may be performed in a separate device outside the freeze dryer together with the step of injecting the above-mentioned dissolution liquid 6, and in the freeze dryer. In some cases, it may be pushed to the position of the intermediate plug portion 15.

(Part 2) The syringe barrel body 1 which has finished the freeze-drying process of the injected drug solution is carried out from the freeze-drying chamber in an open state, and is capped under a sterile dry air (nitrogen) pressure adjusting equipment as a separate device. The syringe barrel main bodies 1 ... Are sequentially sent to immediately below the container, the inside of the syringe barrel body 1 is adjusted to a predetermined pressure with sterile dry air (nitrogen), and the intermediate plug 50 is stoppered. Is pushed to a predetermined position, the above-mentioned dissolution liquid 6 is injected, and the liquid chamber stopper 51 is plugged.

[0021]

Among the above-mentioned prior arts, the problem to be solved by the present invention is that the dry chemical substance 4 in the manufacturing process in which the dry chemical substance 4 and the solution 6 are enclosed in the syringe barrel body 1. This is the difficulty of the sealing process using the intermediate plug 50.

In the above-mentioned prior art (No. 1), when freeze-drying is completed, aseptically filtered highly clean dry nitrogen gas is introduced to a predetermined pressure and sealed in a freeze-drying chamber in a vacuum state. It is highly clean, has low humidity, and can be sealed with oxygen blocked. However, the efficiency and cost are significantly lower than those of freeze-drying which is currently performed in vials.

This is because, in the case of the stopper of the vial, FIG.
As described above, the rubber stopper 91 for sealing the opening 90 in the upper portion of the vial 9 is partially inserted into the opening 90 of each vial 9 while leaving a part of the cutout portion 911 of the lower stopper portion 910 as the vent hole 9a. Since it is placed on the shelf of the freeze-drying chamber of the freeze-dryer, it does not require accurate positioning of the opening 90 of the vial 9 and the rubber stopper 91, and the stopper is closed in half. The placed vials 9 are placed on a shelf, and after the drying is completed, only the space between the shelves is compressed by the shelf up / down drive device, and the rubber stopper 91 is completely stoppered from a half stoppered state to complete sealing. it can. However, in the case of the syringe barrel body 1 of the drug container / syringe A, the intermediate plug 50 having a function of sealing the dry drug 4 has a role of a piston head when the syringe barrel body 1 functions as a syringe barrel. Therefore, the lower surface of the intermediate plug 50 needs to be flat so that the drug solution can be pushed out without remaining, and a cutout for a vent hole cannot be provided in the lower portion of the intermediate plug 50. Top opening 11
In addition, there is a restriction that it cannot be set to the half stoppered state. Thousands to tens of thousands of syringe barrels 1 are separated upward from the openings 11 of the injection barrel body 1, and the same number of intermediate plugs 50 are provided directly above the openings 11.
In order to properly arrange and support the push rod 71 and the push rod 71, a complicated holder 70 is required. Moreover, the holder 7
When setting the syringe barrel 1, the intermediate stopper 50, and the push rod 71 to 0, it is not only necessary to perform a complicated aseptic process, but for this purpose, the syringe barrels 1 ... It cannot be placed on the shelves, and the number accommodated in the freeze-drying chamber is reduced to about 60% of the dense state. Because of this, the cost becomes remarkably high. Therefore, in the past, the above-mentioned means (No. 2) was adopted more often.

According to the conventional technique of (No. 2), the insertion of the intermediate plug 50 is carried out after the injection barrel main body 1 ... Having finished the freeze-drying of the injected drug solution is carried out from the freeze-drying chamber of the freeze-dryer. To a predetermined position of one intermediate stopper capping machine, which is fixed by another device, is sequentially fed by a conveyor line, is sequentially set at the predetermined position, and the intermediate plug 50 is stoppered. It is the process of sending out to the injection device. Therefore,
The injection barrel body 1 that has been freeze-dried of the injected drug solution will be carried out to the outside of the freeze-dryer with the open state.
It is difficult to achieve the same high level of sealing, contamination prevention, moisture absorption prevention, and oxidation prevention as in the freeze dryer.

During the long-term distribution of the product as a product in which the dry medicine 4 and the solution 6 are enclosed in the syringe barrel body 1,
Prevent the accident that the intermediate stopper 50 moves up or down due to the pressure difference between the pressure in the dry chemical chamber 13 and the external pressure, and the solution 6 leaks to the outside of the syringe barrel body 1 or to the dry chemical chamber 13. Therefore, in the stoppering device of the intermediate stopper 50, the injection pressure continuously supplied from the conveyor line while controlling the air (nitrogen) pressure inside the syringe barrel body 1 to an accurate level in consideration of the temperature during the distribution period. The cylinder body 1 must be provided with a function of plugging the intermediate plug 50. Oxygen exclusion, nitrogen replacement, dehumidification, sterile dust-free,
It is a manufacturing cost difficulty to equip the intermediate stopper 50 stopper device with these functions without using the freeze dryer originally having the highest degree of precision control of atmospheric pressure.

[0026]

[Purpose] The present invention has been made in order to solve the above-mentioned problems that have occurred in conventional means, and in a drug container / syringe A, a dry drug 4 is sealed in the barrel body 1 of the drug container / syringe A. While the intermediate stopper 50 does not impair the function as a piston head for ejecting a drug solution when used as a syringe, while the drug solution injected into the syringe barrel body 1 is freeze-dried to the dry drug 4, the syringe barrel body 1 It is an object of the present invention to provide a new means that can be attached to the opening 11 at the upper end of the container as a half stoppered state.

[0027]

As a means for achieving the above-mentioned object, the present invention provides a nozzle part for mounting an injection needle on the bottom bottom part of a cylindrical part, and the nozzle part is made of a rubber material. Install a hole plug, and in the cylindrical part above the hole plug, in order from bottom to top, the dry chemical chamber that contains the dry chemical, the liquid bypass that expands a part of the cylinder wall, and the intermediate An intermediate plug portion for inserting a stopper, a dissolution liquid chamber for storing a dissolution liquid,
In the syringe barrel body of the drug container / syringe in which the liquid chamber plug portion into which the liquid chamber plug is inserted and formed, a part of the barrel wall is expanded to the barrel wall of the cylindrical portion above the intermediate plug portion. 1
One to several ventilation bypasses are formed at substantially the same height position, and both upper and lower ends of the ventilation bypass are located on the inner surface of the cylinder wall, and the vertical length thereof is the outer circumference of the intermediate plug. The present invention provides a syringe barrel main body for a drug container / syringe, which is characterized in that the thickness is set longer than the thickness above and below the surface.

[0028]

In this way, the intermediate stopper 50 is attached to the opening 11 at the upper end of the syringe barrel body 1 with the lower surface of the intermediate stopper 50 kept flat and in a half stoppered state during the freeze-drying process of the drug solution. When the freeze-drying is completed, in the freeze-drying chamber of the freeze-dryer, the chamber can be sealed to the full stopper state simply by adjusting the shelf interval after adjusting the pressure to a predetermined pressure with aseptic dry nitrogen gas. As a result, the dry medicine 4 can be enclosed in the syringe barrel body of the medicine container / syringe at low cost by utilizing the function and control function of the freeze dryer.

[0029]

Embodiments Next, embodiments will be described in detail with reference to the drawings. The same reference numerals are used for the constituent elements having the same effect as those of the conventional means.

FIG. 14 is a vertical sectional front view of the syringe barrel body 1 of the medicine container / syringe A according to the present invention. In FIG.
Reference numeral 1a denotes a cylindrical portion, 10 denotes a nipple-shaped nozzle portion for mounting an injection needle 2 formed at a bottom bottom portion of the cylindrical portion 1a, 11 denotes an opening at an upper end of the cylindrical portion 1a, and the nipple-shaped nozzle portion 1
A hole stopper 52 made of a rubber material such as synthetic rubber is fitted into its inner cavity of 0, and a dry chemical chamber accommodating the dry chemical 4 in the cylindrical portion 1a in order from the bottom to the top. 13,
Liquid passage bypass 14 in which a part of the cylinder wall is expanded, and intermediate plug 50
There are formed an intermediate plug portion 15 into which is inserted, a dissolution liquid chamber 16 that accommodates the dissolution liquid 6, and a liquid chamber plug portion 17 into which the liquid chamber stopper 51 is inserted, and these are those of the conventional means. There is no change.

However, in the cylindrical portion 1a, a ventilation bypass 8 formed by enlarging a part of the cylindrical wall is formed in the cylindrical wall between the intermediate plug portion 15 and the opening 11 at the upper end. There is.

The upper and lower lengths L2 of the ventilation bypass 8 are set to be longer than the upper and lower thickness D1 of the intermediate plug 50 made of a rubber material such as synthetic rubber fitted in the intermediate plug portion 15. And the width W in the circumferential direction thereof is 1
It is set to approximately 10% of the circumferential length of the inner cylindrical surface of a.
It should be noted that the number of ventilation bypasses 8 in this embodiment is two, which are arranged symmetrically as shown in FIG. 15, but in the case of one or in the case of three, the number is appropriately selected. . Further, when the number of ventilation bypasses 8 is set to a plurality, the ventilation bypasses 8 are formed at the same height position on the cylinder wall of the cylindrical portion 1a. The ventilation cross-sectional area of the ventilation bypass 8 may be about 5 mm ² . This is the same when the desired number of ventilation bypasses 8 is selected, and the total of the ventilation cross-sectional areas may be set to about 5 mm ² .

Next, FIG. 16 uses the above-described syringe barrel main body 1 according to the present invention, and the dry chemical chamber 13 in the cylindrical portion 1a thereof.
It is explanatory drawing at the time of injecting a chemical | medical solution into and carrying out the freeze-drying process by the freeze dryer.

The syringe barrel body 1 has a hole plug 52 made of a rubber material such as synthetic rubber fitted in the inner cavity of the nozzle portion 10 at the bottom of the lower end thereof, and a rubber material protective cover 53 at the lower end of the nozzle portion 10. With the nozzle mounted, the nozzle part 10 is supported by a holder in the shape of a test tube in an upright position with the lower end positioned, and a predetermined amount of chemical solution is injected into the dry chemical chamber 13 in the cylindrical part 1a to freeze-dry the product. When the drug solution is placed on the tray of the freeze-drying chamber and the drug solution is freeze-dried by the operation of the freeze-dryer, the state shown in FIG. 16 is set after the drug solution is injected and before the drug solution is carried into the freeze-drying chamber.

That is, the intermediate plug 50 made of a rubber material such as synthetic rubber is inserted into the cylindrical portion 1a of the injection cylinder body 1 up to the position where the ventilation bypass 8 is provided.

Since the width W of the ventilation bypass 8 in the circumferential direction is about 10% of the length of the inner circumferential surface of the cylindrical portion 1a in the circumferential direction,
Even if four ventilation bypasses 8 are provided so as to be arranged side by side in the circumferential direction, the remaining 60% of the inner peripheral surface of the cylindrical portion 1a comes into sliding contact with the outer peripheral surface of the inserted intermediate plug 50. so,
The friction between them holds them firmly in the inserted position.

In this state, the dry chemical chamber 13 at the bottom of the cylindrical portion 1a and the opening 11 at the upper end of the cylindrical portion 1a have the intermediate plug 5
It will be communicated through the ventilation bypass 8 located on the outer periphery of 0. Therefore, in the syringe barrel body 1, the intermediate stopper 50 is inserted into the half-stopped state with the prescribed amount of the drug solution to be freeze-dried. Then, after the half stoppering process with the intermediate plug 50 is completed, the intermediate plug 50 is further
The push rod 71 is placed on the above in an upright posture.

The step of carrying in the freeze-drying chamber and freeze-drying the drug solution is performed in this state. The water vapor to be removed from the chemicals during the freeze-drying primary drying and secondary drying processes is injected by bypassing the peripheral surface of the intermediate stopper 50 via the ventilation bypass 8 as shown by the thin line arrow in FIG. It is removed to the outside of the cylinder body 1. As is well known, in normal freeze-drying in a vial, even if the bottom area of the vial is 4 to 6 times the bottom area of the drug container / syringe, the ventilation path of the half stopper rubber stopper notch part (width 5 mm × High 2 mm) 10 mm ² × 2 is common, and since the steam flow rate during the drying process is approximately proportional to the bottom area (that is, the chemical filling area), even if the length of the ventilation path is taken into consideration, Under normal conditions, total 5mm
^With a ventilation cross-section of about ² , the narrowness of the ventilation path does not prevent drying. Two vent bypasses are sufficient under normal conditions.

Next, FIG. 17 is an explanatory view of the step of sealing the dry chemical 4 after the step of freeze-drying the drug solution is completed.

When the drying is completed, sterile filtered dry nitrogen gas is introduced into the freeze-drying chamber in a vacuum state up to a predetermined pressure, and thereafter, the tray up-and-down drive mechanism for raising and lowering the trays causes the intervals between all the trays in the freeze-drying chamber. Is compressed until the flange portion at the upper end of the push rod 71 contacts the upper end surface of the syringe barrel body 1, and the intermediate plug 50 pushed by this passes through the ventilation bypass 8.
By reaching the intermediate plug portion 15, the dry chemical 4 is completely sealed. It should be noted that the nitrogen gas pressure introduced before the step of full stoppering performed by pushing down the push rod 71 causes the movement of the intermediate stopper 50 when the intermediate stopper 50 is pushed to the position of the intermediate stopper portion 15. Dry chemical chamber 13 compressed by
This is for accurately controlling the internal pressure to be at a level equal to atmospheric pressure, which allows the syringe barrel body 1 to be placed under atmospheric pressure during the subsequent steps and product distribution. This prevents the intermediate plug 50 from moving due to the pressure difference between the pressure inside the dry chemical chamber 13 and the atmospheric pressure.

Next, FIG. 18 is an explanatory view of a step of filling the dissolving liquid 6 after the stoppering step with the intermediate stopper 50. The syringe barrel body 1 with the intermediate stopper 50 plugged is transferred from the freeze dryer to a separate device under a sterile clean laminar air blowing facility, thus keeping the solution chamber 16 sterile and dust-free. Be done.
In the embodiment of FIG. 16, the upper end of the push rod 71 has a lid-like shape to more carefully protect the carried-out dissolution liquid chamber 16 of the syringe barrel body 1 from contamination. First, the push rod 71 is removed (in some embodiments, after the intermediate stopper 50 is accurately moved to the intermediate stopper portion 15), a predetermined amount of the solution 6 is injected to a level at which the liquid chamber stopper portion 17 remains. Next, the air on the liquid surface of the dissolving liquid 6 is exhausted, or the hollow needle is penetrated through the liquid chamber stopper 51 made of a rubber material to remove the air, and the liquid chamber stopper 51 is inserted into the liquid chamber stopper portion 17. In the state of 18, the step of enclosing the solution 6 is completed.

In this way, the operation of using the syringe barrel body 1 in which the dried chemicals 4 and the solution 6 thereof are enclosed as a syringe is the same as that of the above-mentioned prior art, and the operator does not use the conventional technique. There is no additional burden or duty of care that goes beyond the law. As in the embodiment of FIG. 16, the position where the ventilating bypass 8 is provided is relatively low, and when the liquid chamber plug 51 passes through the ventilating bypass 8 part, the dissolving liquid 6 is discharged.
4 may leak back to the upper surface side of the liquid chamber stopper 51, in order to prevent this reliably, the upper and lower thickness D2 of the liquid chamber stopper 51 should be smaller than the upper and lower length L of the liquid bypass 14. Produce long (D2 <L1).

Next, FIG. 19 shows another embodiment.
In this embodiment, the ventilation bypass 8 is provided close to the opening 11 at the upper end of the cylindrical portion 1a, and the intermediate plug 50 has a thickness D1 above and below the length L2 above and below the ventilation bypass 8.
By forming the diameter-reduced portions 50a in the upper and lower intermediate portions of the outer peripheral surface of the body which are formed thicker, the intermediate plug 50 fitted in the half-stopped state can be inserted into the push rod 71. This is an example in which the vertical driving mechanism of the shelves installed in the freeze-dryer reduces the vertical distance between the shelves without using it, so that the process of capping all can be performed on the back side of the shelves.

In this embodiment, a dry chemical chamber 1 is provided in a cylindrical portion 1a having an opening 11 at the upper end and a nozzle portion 10 at the bottom of the lower end.
3, passage bypass 14, intermediate plug portion 15, dissolution liquid chamber 16,
In contrast to the conventional syringe barrel body 1 formed with the liquid chamber plug portion 17,
Regarding the provision of one or a plurality of ventilation bypasses 8 by expanding a part of the cylindrical wall between the intermediate plug portion 15 and the opening 11 at the upper end of the cylindrical portion 1a, it is the same as the above-described embodiment. Although there is no change, the ventilation bypass 8 is provided at a portion very close to the opening 11 at the upper end of the cylindrical wall of the cylindrical portion 1a as shown in FIG. The width W of each of the one to several ventilation bypasses 8 is set to about 10% of the length in the circumferential direction of the inner peripheral surface of the cylindrical portion 1a of the syringe barrel body 1 as in the above-described embodiment. It is set, but the length L2 above and below it
Is formed to be shorter than the vertical length L1 of the liquid bypass 14, and the intermediate plug 50 is formed with a reduced diameter portion 50a at the upper and lower intermediate portions of the body peripheral surface thereof. .

Then, the intermediate plug 50 and the ventilation bypass 8
And the head portion of the cylindrical portion 1a are set to have the following relationship. That is, as shown in FIG. 23, the vertical thickness D1 of the intermediate plug 50 is longer than the vertical length L2 of the ventilation bypass 8 (D1> L2), and the diameter r of the reduced diameter portion 50a of the intermediate plug 50 is r. Is manufactured to be thinner than the inner diameter R of the cylindrical portion 1a, as shown in FIG. In addition, the thickness d1 of the reduced diameter portion 50a of the intermediate plug 50 is determined from the upper end of the ventilation bypass 8 to the opening 1 of the cylindrical portion 1a.
It is thicker than the height h up to 1 (d1> h). Also,
The thickness d3 of the stopper lower portion 50c of the intermediate stopper 50 is the ventilation bypass 8
Is shorter than the length L2 (d3 <L2). Further, the length L1 of the liquid passage bypass 14 is made longer than the thickness D1 of the intermediate plug 50 as shown in FIG. 19 (L1> D1).

(Half stoppered state after injection of the chemical solution and before loading into the freeze dryer) FIG. 19 shows the syringe barrel body 1 in which the chemical solution to be freeze-dried is injected into the dry chemical chamber 13 in the freeze-drying chamber of the freeze-drying machine. Before being carried in, an intermediate plug 50 is inserted and inserted into the opening 11 at the upper end of the syringe barrel body 1 to show a half-stopped state. As shown in the figure, the intermediate stopper 50 is located at a position where the middle of the upper stopper portion 50b and the intermediate reduced diameter portion 50a is higher than the opening 11 at the upper end of the syringe barrel body 1, and the lower stopper portion 5 of the intermediate stopper 50 is located.
0c is located substantially in the middle of the top and bottom of the ventilation bypass 8.
Since the width W of the ventilation bypass 8 is about 10% of the length in the circumferential direction of the inner peripheral surface of the cylindrical portion 1a of the syringe barrel body 1, even if four ventilation bypasses 8 are provided, the middle The stopper 50 is firmly held in the above-mentioned half stopper position by the friction of the peripheral surface 60% of the stopper lower portion 50c.

(State in Freeze-Drying Process) The water vapor to be removed from the chemical solution injected into the dry chemical chamber 13 in the process of primary drying and secondary drying of the freeze-drying is the thin line drawn in FIGS. 19 and 23. As indicated by the arrow, the peripheral surface of the plug lower portion 50c of the intermediate plug 50 is bypassed via the ventilation bypass 8, and the peripheral surface of the intermediate reduced diameter portion 50a of the intermediate plug 50 and the cylindrical portion 1 are bypassed.
It passes through the gap between the inner peripheral surface of a and is removed to the outside of the syringe barrel body 1. As is well known, in ordinary freeze-drying in a vial, even if the bottom area of the vial 9 is 4 to 6 times the bottom area of the injection barrel body 1, the stopper lower part of the rubber stopper 91 is a half stoppered state. Vent hole 9a of notch provided in 910
(Width 4 mm × height 2.5 mm) is generally 10 mm ² × 2, and since the steam flow rate in the drying process is approximately proportional to the bottom area (that is, the chemical surface area), the length of the ventilation bypass 8 is slightly long. Even if this is taken into consideration, under normal conditions, if the total ventilation cross-sectional area is about 5 mm ² , the narrowness of the ventilation bypass 8 does not prevent drying. Normally ventilation bypass 8
Since two pieces are provided, the intermediate reduced diameter portion 50 of the intermediate plug 50
The gap between the peripheral surface of a and the inner peripheral surface of the cylindrical portion 1a is 0.3 m.
It may be about m to 0.5 mm.

(Sealing with all stoppers after completion of drying) When drying is completed, sterile filtered nitrogen gas is introduced to a predetermined pressure in a freeze-drying chamber in a vacuum state, and thereafter, the trays installed in the freeze-dryer are moved up and down. By the drive mechanism, the upper and lower intervals of the shelves in the freeze-drying chamber are inserted into the opening 11 at the upper end of the syringe barrel body 1 mounted on the holder 70 in a shelf shape.
By compressing the upper surface of the intermediate plug 50 until the upper surface thereof coincides with the end surface of the opening 11 of the syringe barrel body 1, so that the lower surface of the intermediate plug 50 reaches below the lower end of the ventilation bypass 8 as shown in FIG. The freeze-dried dry chemical 4 is completely sealed. In addition, the opening 11 at the upper end of the syringe barrel body 1
Is completely sealed by the upper surface of the intermediate stopper 50, the intermediate stopper 50 is transferred from the freeze-drying chamber of the freeze dryer to the next step (solution injection, etc.). As long as it is not sucked into the inside of the syringe barrel 1, the floating dust in the atmosphere is prevented from falling into the solution chamber 16 inside the syringe barrel body 1.

Therefore, the shape and dimensions of the intermediate plug 50 are manufactured so that the static frictional force between the intermediate plug 50 and the inner surface of the cylinder wall of the injection cylinder body 1 withstands a differential pressure of 0.5 atm, or an injection is performed. The diameter of the opening 11 at the upper end of the cylinder body 1 may be slightly reduced, or some small protrusions (stoppers) protruding inward may be provided at the rim of the opening 11 at the upper end, and the intermediate plug 50 may be attached in the next step. Until the intermediate plug 50 is pushed into the position, the intermediate plug 50 is
It is desirable to manufacture it so that it is fixed to the fully capped head in the freeze dryer (not shown). The former intermediate plug 5
In the case of the means for selecting the shape and size of 0, the force required to push the plunger 3 when used as a syringe is only a little, and the usability is not impaired and the rim of the opening 11 of the latter syringe barrel body 1 is When using a means to provide a small projection, the capping force at the time of full stoppering before entering the freeze dryer in the manufacturing process and the total stoppering inside the freeze dryer is slightly increased, and there is no effect when used as a syringe. do not do. This makes it easier and more reliable to keep the solution chamber 16 as well as the dry drug chamber 13 in the syringe barrel 1 in the drug container / syringe A aseptic and dust-free.

It should be noted that the nitrogen gas pressure introduced before all stoppers is the dry chemical chamber below the intermediate stopper 50 when the intermediate stopper 50 is pushed to the position of the intermediate stopper portion 15 in the syringe barrel body 1. Since 13 is accurately controlled to the level that is atmospheric pressure,
As shown in FIG. 20, the atmospheric pressure in the injection barrel body 1 when fully capped is a based on the cylinder lengths a and b shown in FIG.
/ B Atmospheric pressure, but about b ≧ 0.55 due to the function of the drug container / syringe for freeze-dried preparation (as described in the description of the prior art).
a. Therefore, if the static frictional force between the intermediate plug 50 and the inner surface of the barrel wall of the syringe barrel body 1 at the opening 11 at the upper end of the syringe barrel body 1 withstands the differential pressure of 0.5 atm, it is forced in the next step. The intermediate plug 50 is not sucked into the syringe barrel body 1 until the intermediate plug 50 is pushed into.

(Injection of dissolution liquid and stopper of liquid chamber stopper) Intermediate stopper 5
In the state shown in FIG. 20 in which all 0s have been stoppered, the syringe barrel body 1 is transferred from the freeze dryer to another device under a sterile clean laminar air blowing facility, and first, the stoppered intermediate stoppers 50 are The upper surface is Hmm (several mm) from the intermediate plug portion 15 in the syringe barrel body 1.
Push it in until it reaches a high position and then inject a certain amount of the lysate 6 to the level of the lower end of the aeration bypass 8.
In other words, the above-described height H is determined so that the liquid level of the predetermined amount of the solution 6 matches the level of the lower end of the ventilation bypass 8. Subsequently, the liquid chamber stopper 51 is capped with the liquid chamber stopper 51.

The shape of the liquid chamber stopper 51 is similar to that of the intermediate stopper 50 except that a female screw for mounting the plunger 3 is provided on the upper surface thereof. This is because the lower surface of the liquid chamber stopper 51 reaches the lower end of the ventilation bypass 8, that is, the liquid surface of the dissolving liquid 6, which is located on the liquid surface of the dissolving liquid 6
This is because the air of (4) is eliminated by using the ventilation bypass 8 as shown by the thin arrow in FIG. 21 as the liquid chamber stopper 51 descends. Therefore, when plugging the liquid chamber stopper 51,
As in the prior art, the air in the syringe barrel body 1 located on the liquid surface of the dissolving liquid 6 is capped while being exhausted by placing it under vacuum, or the liquid chamber stopper 51 made of a rubber material is provided with a hollow needle. There is no need to pierce and plug while removing air. After the lower surface of the liquid chamber stopper 51 reaches the lower end of the ventilation bypass 8, that is, the liquid surface of the dissolving liquid 6, the liquid chamber stopper 51 is further pushed in by a depth corresponding to the depth of H described above. Since the solution 6 is filled between the liquid chamber stopper 51 and the intermediate stopper 50, the intermediate stopper 50 moves downward together with the liquid chamber stopper 51 by the depth of H and reaches the predetermined intermediate stopper portion 15. (FIG. 22).

Next, FIG. 26 is an explanatory view of the shape and dimensions of the liquid chamber stopper 51 described above. When striking the liquid chamber stopper 51,
The conditions of the shape and size of the liquid chamber stopper 51 for naturally eliminating the air on the liquid surface of the dissolving liquid 6 injected into the dissolving liquid chamber 16 from the inside of the injection cylinder body 1 by using the ventilation bypass 8 are as described above. 23, 24, and 25, which are similar to the conditions of the shape and size of the intermediate plug 50. That is, the liquid chamber stopper 51 has the cylindrical portion 1a of the syringe barrel body 1 at the upper and lower intermediate portions of the peripheral surface thereof.
A reduced diameter portion 51a having a diameter smaller than the inner diameter of the reduced diameter portion 51a is formed, and the thickness d4 above and below the reduced diameter portion 51a is the height from the upper end of the ventilation bypass 8 to the edge of the opening 11 at the upper end of the cylindrical portion 1a. It is formed longer than h. Further, the reduced diameter portion 51 of the liquid chamber stopper 51
The thickness d6 of the lower plug portion 51c below a is the ventilation bypass 8
Is smaller than the length L2 above and below and the reduced diameter portion 51
The total thickness (d4 + d6) of the thickness d4 of a and the thickness d6 of the lower plug portion 51c is from the lower end of the ventilation bypass 8 to the cylindrical portion 1
It is formed to be thicker than the height L3 of the opening 11a to the edge of the opening 11.

When this liquid chamber stopper 51 is used, the total length of the medicine container / syringe A is somewhat longer than that of the conventional product shown in FIGS. 1 to 5, but it is used as a syringe. The operation at the time is the same as the conventional product, and does not impose an additional burden and a duty of attention on the user beyond the conventional method.

[0055]

As described above, according to the means of the present invention, the function of the intermediate plug 50 for sealing the dry chemicals 4 in the syringe barrel body 1 when used as a syringe is impaired. In order to freeze-dry the drug solution injected into the dry drug chamber 13 of the syringe barrel body 1, the dry drug 4 can be attached to the barrel body 1 as a half stopper during the freeze-drying process of the drug solution. In addition, when the syringe barrel body 1 is supported by the holder 70 and placed on the shelf in the freeze-drying chamber of the freeze-dryer, even if the syringe barrels 1 are arranged in a dense state, they are frozen normally after freeze-drying. The tray vertical drive device provided in the dryer can compress the vertical spacing between the trays and push the intermediate stopper 50 on the back side of the tray to seal the dry chemicals by all stoppers.

By this, the use of a complicated holder required for sealing in the freeze-dryer in the prior art, or the sterile dust-free nitrogen substitution, nitrogen substitution, and accuracy required for sealing outside the freeze-dryer in the conventional technology. No need for decompression adjustment / equipment.

Further, the ventilation bypass 8 is provided at a position close to the opening 11 at the upper end of the cylindrical portion 1a of the injection cylinder body 1,
By forming a reduced diameter portion 50a having a diameter smaller than the inner diameter of the cylindrical wall of the cylindrical portion 1a at the upper and lower intermediate portions of the peripheral surface of the intermediate stopper 50, the intermediate stopper 50 mounted in a half stoppered state can be It is an operation that compresses the vertical spacing of the shelves so that it can be pushed into all tapping positions without using auxiliary tools.

Further, similarly to the intermediate plug 50, the liquid chamber plug 51 is formed with a reduced diameter portion 51a having a diameter smaller than the inner diameter of the cylindrical wall of the cylindrical portion 1a at the upper and lower intermediate portions of the peripheral surface. With the similar shape and size, after the intermediate stopper 50 is pushed to a predetermined position of the intermediate stopper portion 15, the dissolving liquid 6 is injected into the dissolving liquid chamber 16 defined above it, When the liquid chamber stopper 51 is closed by plugging, the air above the liquid level of the dissolving liquid 6 in the dissolving liquid chamber 16 can be naturally eliminated by utilizing the ventilation bypass 8, and in the conventional means. This makes it possible to eliminate the need for equipment and operation for eliminating the air in the syringe barrel body 1 which is required when the liquid chamber stopper is plugged.

[Brief description of drawings]

FIG. 1 is a partially cutaway front view of a syringe barrel body in a conventional drug container / syringe.

FIG. 2 is a transverse plan view taken along line II-II of the above.

FIG. 3 is a front view of the intermediate plug of the above.

FIG. 4 is a front view of the above liquid chamber stopper.

FIG. 5 is a partially cutaway front view of the same state in which the dry chemical and the solution are enclosed.

FIG. 6 is an explanatory diagram of an operation procedure when the syringe barrel body of the above is used as a syringe.

FIG. 7 is an explanatory diagram of a step of pouring a solution of the above-mentioned syringe barrel body into a dry chemical.

FIG. 8 is an explanatory view showing a state in which the step of pouring the solution of the syringe barrel body has been completed.

FIG. 9 is an explanatory diagram of a process of expelling air from the syringe barrel body before using the syringe barrel body as a syringe of the same.

FIG. 10 is an explanatory view of a holding state of the intermediate stopper when the medicine injected into the syringe barrel body of the conventional medicine container / syringe is freeze-dried.

FIG. 11 is an explanatory view showing a half stoppered state of a rubber stopper fitted into an opening of a vial when a drug is freeze-dried using a conventional vial.

FIG. 12 is a front view of the above rubber stopper.

FIG. 13 is a bottom view of the above rubber stopper.

FIG. 14 is a partially cutaway front view of a syringe barrel body of a drug container / syringe according to the present invention.

15 is a cross-sectional view of the syringe barrel main body taken along line CC in FIG. 16.

FIG. 16 is a vertical cross-sectional front view showing a state where the intermediate stopper is half-stoppered during the freeze-drying process of the syringe barrel body.

FIG. 17 is a vertical cross-sectional front view showing a state in which the intermediate stoppers are all stoppers after the freeze-drying step of the syringe barrel body is completed.

FIG. 18 is a vertical cross-sectional front view of the same syringe barrel main body in a state in which a solution liquid is further injected and the liquid chamber stopper is sealed after all the intermediate stoppers have been stoppered.

FIG. 19 is a vertical cross-sectional front view of another embodiment of the syringe barrel body of the present invention with the intermediate stopper fitted into the half stopper.

FIG. 20 is a vertical cross-sectional front view showing a state where all the intermediate stoppers of the above-mentioned syringe barrel main body are stoppered.

FIG. 21 is an explanatory view of a process of injecting a dissolving liquid and sealing the liquid chamber stopper after the intermediate stopper of the syringe barrel body is pushed into a predetermined position.

FIG. 22 is a vertical cross-sectional front view of the above-mentioned syringe barrel main body with a liquid chamber stopper sealed.

FIG. 23 is a vertical cross-sectional front view of a main portion of the injection barrel body with the intermediate stopper inserted into the half stopper.

FIG. 24 is a cross-sectional view taken along the line AA in FIG.

FIG. 25 is a sectional view taken along the line BB in FIG.

FIG. 26 is a vertical cross-sectional front view of a main part in a state in which the liquid chamber stopper of the above-mentioned syringe barrel body is fitted into the half stopper.

[Explanation of symbols]

A ... Medicine container / syringe, 1 ... Injection cylinder body, 1a ... Cylindrical part, 10 ... Nozzle part, 10a ... Cap body, 10b ... Proximal end part, 11 ... Opening, 13 ... Dry chemical chamber, 14 ... Liquid passing bypass, 15 ... Intermediate stopper part, 16 ... Dissolution chamber, 17 ... Liquid chamber stopper part, 2 ... Injection needle, 3 ... Plunger, 4 ... Dry chemical, 5
0 ... intermediate stopper, 50a ... reduced diameter portion, 50b ... upper stopper, 50c
... lower part of stopper, 51 ... liquid chamber stopper, 51a ... reduced diameter portion, 510 ... female screw, 52 ... hole stopper, 53 ... protective cover, 6 ... dissolution liquid, 7
0 ... Metal holder, 71 ... Push rod, 8 ... Vent bypass, 9 ... Vial, 9a ... Vent hole, 90 ... Opening, 91 ...
Rubber stopper, 910 ... Lower portion of plug, 911 ... Notch, M ... Chemical solution, W ... Width, L ... Length, D ... Thickness, R ... Inner diameter.

[Procedure amendment]

[Submission date] August 6, 1993

[Procedure Amendment 1]

[Document name to be amended] Statement

[Name of item to be amended] Claims

[Correction method] Change

[Correction content]

[Claims]

Claims (3)

[Claims] 1. A nozzle portion 10 for mounting an injection needle 2 is provided at a bottom bottom portion of a cylindrical portion 1a, and a hole plug 52 made of a rubber material is attached to the nozzle portion 10, and a cylindrical portion above the hole plug 52. 1a, in order from the bottom to the top, a dry chemical chamber 13 for containing the dry chemical 4, a liquid bypass 14 having a partially expanded cylindrical wall, and an intermediate plug portion 15 into which an intermediate plug 50 is fitted. In the syringe barrel body 1 of the drug container / syringe in which the solution chamber 16 for containing the solution 6 and the solution chamber plug 17 for inserting the solution chamber stopper 51 are formed, a cylinder above the intermediate stopper 15 On the cylinder wall of the portion 1a, one to several ventilation bypasses 8 each having a partially expanded diameter are formed to be aligned at substantially the same height position, and the ventilation bypasses 8 are arranged above and below it. Both ends of the intermediate plug 5 are located on the inner surface of the cylindrical wall, and the vertical length of the intermediate plug 5 is
A syringe barrel main body in a drug container / syringe, characterized in that it is formed to have a thickness longer than the upper and lower outer peripheral surfaces of 0. 2. A nozzle portion 10 for mounting an injection needle 2 is provided on a bottom bottom portion of a cylindrical portion 1a, and a hole plug 52 made of a rubber material is attached to the nozzle portion 10 and a cylindrical portion above the hole plug 52. 1a, in order from the bottom to the top, a dry chemical chamber 13 for containing the dry chemical 4, a liquid bypass 14 having a partially expanded cylindrical wall, and an intermediate plug portion 15 into which an intermediate plug 50 is fitted. In the syringe barrel body 1 of the drug container / syringe in which the solution chamber 16 for containing the solution 6 and the solution chamber plug 17 for inserting the solution chamber stopper 51 are formed, a cylinder above the intermediate stopper 15 On the cylinder wall of the portion 1a, one to several ventilation bypasses 8 each having a partially expanded diameter are formed to be aligned at substantially the same height position, and the ventilation bypasses 8 are arranged above and below it. Both ends of which are located on the inner surface of the cylinder wall, and the vertical length L2 is above the outer peripheral surface of the intermediate plug 50. The intermediate plug 50 is formed to have a thickness smaller than the lower thickness D1 and has a reduced diameter portion 50a having a diameter smaller than the inner diameter of the cylindrical portion 1a of the injection barrel body 1 at the upper and lower intermediate portions of the outer peripheral surface.
And the thickness d1 above and below the reduced diameter portion 50a.
Is shorter than the vertical length L2 of the ventilation bypass 8,
Further, the total thickness D1 of the upper and lower sides of the intermediate stopper 50 is formed to be thinner than the upper and lower length L1 of the liquid passage bypass 14, the syringe barrel body in the medicine container / syringe. 3. A liquid chamber stopper (51) is provided with a reduced diameter portion (51a) having a diameter smaller than the inner diameter of the barrel wall of the barrel portion (1a) of the injection barrel body (1) at intermediate portions above and below the peripheral surface thereof. The syringe barrel main body for a drug container / syringe according to claim 2, wherein the syringe barrel main body is formed in a shape and size similar to 50.